Recalls / Class II

Class IID-0064-2016

Product

CHORIONIC GONADOTROPIN, Injectable Solution, 200 UNITS/0.1 ML, vial sizes: 4 mL; 5 mL; 6 mL; 7.5 mL ; 9 mL, 10 mL; 12 mL; 15 mL; 20 mL; 28 mL; Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

Affected lot / code info

11032014@10, 12082014@3, t01082015@26, t03092015@26, t03132015@13, t03162015@12, t03242015@19, t04092015@21, t05132015@28, t05132015@44, t05202015@22, t05262015@14, t05272015@36, t06172015@27, t06182015@7, t06242015@9, t06292015@11, t07092015@42, t07102015@25, t08012014@1, t09122014@19, t09252014@4, t12242014@2, and t12312014@8.

Why it was recalled

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Recalling firm

Firm

JD & SN Inc., dba Moses Lake Professional Pharmacy

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

1555 Pilgrim St, N/A, Moses Lake, Washington 98837-4623

Distribution

Quantity

9 (4mL), 4 (5mL) vials, 9 (6mL) vials, 5 (7.5mL) vials, 4 (10mL) vials, 5 (9mL) vials, 3 (12mL) vials, 2 (15mL) vials, 1 (20mL), 1 (28mL) vials

Distribution pattern

Nationwide

Timeline

Recall initiated

2015-07-24

FDA classified

2015-10-27

Posted by FDA

2015-11-04

Terminated

2016-04-13

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0064-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.